Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension

Sponsor

University of Texas at Austin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05233865

Collaborator

(none)

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to understand how blood pressure, heart rate, and symptoms of low blood pressure (such as dizziness or nausea) are affected by positional changes and exercise when on land or in the water for people who tend to experience dizziness upon standing.

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension	Behavioral: Water exercise Behavioral: Land exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Water condition Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing and walking conditions when in a pool.	Behavioral: Water exercise Participants will be asked to sit and stand multiple times (before, immediately after, and 2 hours after a 15-minute walking session). The walking session will consist of 3 minutes of walking at a light intensity followed by 9 min of walking at a moderate intensity and a 3-minute cool down walking at a light intensity. This walking session will occur in a pool.
Active Comparator: Land condition Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing, and walking conditions when on land.	Behavioral: Land exercise Participants will be asked to sit and stand multiple times (before, immediately after, and 2 hours after a 15-minute walking session). The walking session will consist of 3 minutes of walking at a light intensity followed by 9 min of walking at a moderate intensity and a 3-minute cool down walking at a light intensity. This walking session will occur on land.

Arm

Intervention/Treatment

Experimental: Water condition

Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing and walking conditions when in a pool.

Behavioral: Water exercise

Participants will be asked to sit and stand multiple times (before, immediately after, and 2 hours after a 15-minute walking session). The walking session will consist of 3 minutes of walking at a light intensity followed by 9 min of walking at a moderate intensity and a 3-minute cool down walking at a light intensity. This walking session will occur in a pool.

Active Comparator: Land condition

Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing, and walking conditions when on land.

Behavioral: Land exercise

Outcome Measures

Primary Outcome Measures

Systolic blood pressure (mmHg) [<1 minute upon standing]
Blood pressure will be taken with an automated blood pressure device
Diastolic blood pressure (mmHg) [<1 minute upon standing]
Blood pressure will be taken with an automated blood pressure device
Self-reported orthostatic hypotension symptoms [2 minutes]
A self-reported instrument assessing symptoms from low blood pressure experienced upon standing or after prolonged upright activities. Possible scores range from 0 (no symptoms) to 10 (worse possible symptoms)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Self-report of dizziness upon standing (from sit or supine position) or known diagnosis of orthostatic hypotension
Able to stand independently for 3-5 consecutive minutes
Able to walk independently (with or without an assistive devise)
Medically stable for last month
Score of 3 or greater on Mini-Cog (standardized outcome measure to detect dementia)
Full coronavirus vaccination

Exclusion Criteria:

Diagnosis of dementia
Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Aging Research Laboratory at UT Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT05233865

Other Study ID Numbers:

STUDY00001869

First Posted:

Feb 10, 2022

Last Update Posted:

Feb 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension, Orthostatic

Hypotension

Study Results

No Results Posted as of Feb 10, 2022